October 11, 2002 Editorial: Trial Lawyers and Clinical Trials_WSJ Daniel Hennenger, the editor of the Wall Street Journal would give doctors free reign to experiment on human subjects unencumbered by ethical or regulatory considerations: just let every self-proclaimed ” genius who somewhere is dreaming of the next L-dopa, lithium or…
Smallpox Vaccine: Doctor Lists 18 Points You Should Consider October 10, 2002 In her column on Redflagsweekly.com–a website that raises and explores controversial issues in Health and Medical Science–Dr. Meryl Nass spells out 18 sobering reasons why the policy proposed by the Department of Health and Human Services–to vaccinate the…
October 9, 2002 Smallpox Vaccine plan: HHS Messengers Still Stumble_NYT_WP The Administration’s shift in its smallpox vaccination policy is meeting with criticism from medical experts who are unconvinced that it is wise or justified to put millions of people at serious risk in (what amounts to) a massive human experiment–without…
Appeals Court reinstates Nigerian research case against Pfizer Tue, 14 Oct 2003 On Oct. 8, 2003, The US Court of Appeals for the Second District (NY) vacated and remanded the lower District Court decision (Sept. 26, 2002) that had dismissed a lawsuit brought on behalf of Nigerian children and guardians…
<p> Canadian Lawsuit:Autism-Vaccine – Maclean’s </p> <p> Mon, 11 Nov 2002 </p> <p> Dr. Jeffrey Bradstreet: “It’s garbage to say there’s a reason to have residual neurotoxicity in an injectable for a child. It’s not a necessary risk.” </p> <p> While scientists are unsure whether the mercury based vaccine preservative,…
Serious Adverse Reaction in Gene Therapy- France & US Halt Trials October 4, 2002 Gene therapy treatment that appears to cure a rare immune disorder often referred to as "bubble boy disease” or SCID, caused by a mutation of the x chromosome in boys, were suspended in France and the…
Ritalin Outrage: Congress_ Big Media Under the Influence of Big Drugs September 30, 2002 Two hard hitting editorials–one by Nicholas Regush of Redflagsweekly.com. the other by Tony DiGirolamo of CutureShockTV.com focus on the scorge of Ritalin and the victimization of millions of children who are pushed to becoming addicted to…
Subject: NIMH director blames HMOs for ADHD-Ritalin problem_NYPost Date: Fri, 27 Sep 2002 18:08:19 -0400 FYI The NY Post reports that there were heated exchanges at a Congressional hearing convened by the House Government Reform Committee overdiagnosing and overmedicating of children. Dr. Richard K. Nakamura, head of the National Institute…
Subject: NY Post Prompts Cong Hearings re: Children prescribed Ritalin Date: Wed, 25 Sep 2002 14:23:26 -0400 An investigative series by the New York Post re: the pressure brought to bear on parents to medicate their normal children with psychostimulant drugs–despite the risk of addiction and other serious adverse reactions–…
Subject: Kids are “hot ticket” in Rx drug market Date: Thu, 19 Sep 2002 17:39:52 -0400 According to MEDCO Health, which manages prescription drug plans, the records of 500,000 children under age 19 reveal that: “Kids have surpassed senior citizens as the hot ticket in the prescription drug market… Spending…
Do the Ends Justify the Means in Human Research? Thu, 5 Sep 2002 A moral struggle is taking place in which research stakeholders–including medical institutions that profit from biomedical research, and their emissaries in government oversight agencies–argue that ethics should be breached to further the interest of research. Patients’ rights…
Thank you for your considered response to our July 29 letter to the director of the Office of Human Research Protection.
We are astonished to learn that OHRP found that all 12 major research institutions involved in this multi-site trial had violated Federal protections (45 CFR 46.117):
(a) "in all cases OHRP found that the informed consent documents approved by the institutional review boards (IRBs) for the research failed to describe adequately the reasonably foreseeable risks and discomforts of the research."
